Lead Auditor for Management Systems & Processes
Benefit from the expertise and rigor of AAMI faculty as you learn today’s best practices for conducting internal audits and supplier audits for regulatory compliance.
For years, AAMI courses have been the gold standard for training on the implementation of FDA 21 CFR Part 820 Quality System Regulation and ANSI/AAMI/ISO 13485: 2016/(R)2019. Now, auditors can also benefit from the expertise and rigor of AAMI faculty as they learn today’s best practices for conducting internal audits and supplier audits for compliance with FDA, ISO, MDSAP and EU MDR requirements. We’ll also provide coverage of ASQ/ANSI/ISO 19011:2018, Guidelines For Auditing Management Systems.
Over two information-packed, interactive days, participants will learn…
- Current requirements for internal audits in today's international medical device market
- Best practices in the interpretation and application of AAMI and other standards
- How to conduct effective “remote/virtual” QMS audits. (This is “must-have knowledge” during this pandemic!)
- Hands-on advice on how to meet FDA expectations for audit procedures, auditor qualifications and audit records
- The latest on MDSAP and EU MDR status and best practices for working with Notified Bodies
- a copy of ANSI/AAMI/ISO 13485: 2016/(R)2019 (a $249 retail value)
- OnDemand access to the recordings following the event (you don’t have to be available live to take advantage of all the learning)
- a QMS auditing exam qualification record
- access to the AAMI Alumni community group
Please note: This course is being held virtually.
Lead Auditor Course Faculty:
Aaron Snyder currently works at Molnlycke Healthcare as the Global Quality Systems Director located in Gothenburg Sweden. Prior to Molnlycke, he worked at Waters Corporatoin, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of medical devices from simple class I disposable medical devices to advanced class III surgical instruments. He has over 15 years of medical device manufacturing experience which includes 10 years of compliance auditing and 9 years managing quality teams. He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor while at Molnlycke, Waters, and Covidien. He is an expert in medical device quality management systems and an experienced quality manager. He earned the American Society of Quality (ASQ) Six Sigma Black Belt (SSBB) certification in 2005, the Quality Engineer (CQE) certification in 2009, and the Software Quality Engineer (CSQE) certification in 2010. He is an active member of Toastmasters International and has received two advanced communicator gold awards. He has presented hundreds of toastmaster speeches and also won the 2009 District 31 humorous speech contest.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.